CDSCO License for Gastrointestinal endoscopic clip cutter generator
Medical Device Information
Intended Use
A portable, mains electricity (AC-powered) device intended to be used in conjunction with a cutter for the endoscopic removal of a gastrointestinal endoscopic clip.
Gastrointestinal Endoscopic Clip Cutter Generator: Device Overview and Regulatory Importance
The Gastrointestinal endoscopic clip cutter generator is a specialized medical device designed for gastroenterology applications. This portable, mains electricity-powered device plays a critical role in the endoscopic removal of gastrointestinal clips, enhancing procedural safety and efficiency. Given its complexity and risk profile, regulatory compliance under the Central Drugs Standard Control Organization (CDSCO) framework is essential before market entry in India.
Navigating the CDSCO licensing process for a Class C medical device like the gastrointestinal endoscopic clip cutter generator is crucial. Without proper licensure, manufacturers and importers risk regulatory actions, market access denial, and potential legal consequences. With over 25 years of experience assisting 500+ companies, we provide comprehensive insights to streamline your CDSCO approval journey.
CDSCO Regulatory Framework for Gastrointestinal Endoscopic Clip Cutter Generator
The CDSCO regulates medical devices as per the Medical Devices Rules, 2017, classifying devices based on risk. The gastrointestinal endoscopic clip cutter generator falls under Class C, indicating moderate to high risk. This category mandates a centralized licensing procedure involving CDSCO’s Central Licensing Authority.
The device is listed under the notification number 29/Misc./03/2020-DC (182) dated 27.09.2021, confirming its recognition and regulatory applicability within India.
Risk Classification and License Requirements
- Risk Class: C
- Device Category: Gastroenterology
- License Type: MD9 (Manufacturing License for Class C & D devices)
- Regulatory Authority: CDSCO Central Licensing Authority
Class C devices require rigorous scrutiny, including product testing, documentation audits, and facility inspections. The MD9 license ensures your manufacturing processes meet Indian standards for safety, efficacy, and quality.
For more details on classification, refer to our comprehensive Medical Device Classification guide.
Manufacturing License Process (MD9)
Securing an MD9 manufacturing license involves multiple stages:
Obtain Test License (Form MD13): The initial step is acquiring a test license to allow sample testing of your device. This stage typically takes 1.5 to 2 months.
Product Testing: Conduct device testing at CDSCO-approved laboratories to validate safety and performance. Utilize the list of testing laboratories for accredited centers.
Document Preparation: Prepare detailed technical files including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
Application Submission (Form MD7): Submit the manufacturing license application through the CDSCO MD Online Portal.
CDSCO Inspection: Expect an on-site audit of your manufacturing facility by CDSCO inspectors.
Query Resolution: Address any queries raised during inspection or document review promptly.
License Grant (Form MD9): Upon satisfactory compliance, CDSCO grants the MD9 license.
The entire process generally spans 4 to 5 months.
For a detailed step-by-step guide, visit our MD9 License Guide.
Manufacturing License Documents Required
To ensure a smooth application, prepare the following documentation:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control NOC
- Device Master File (DMF) – covering device description, design, labeling, and intended use (Device Master File Guide)
- Plant Master File (PMF) – manufacturing processes, equipment, and quality control measures (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with Indian regulatory standards
- Risk Management File detailing hazard analysis and mitigation strategies (Risk Management Guide)
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification
Maintaining accuracy and completeness in these documents significantly reduces processing delays.
Import License Process (MD15)
If you intend to import the gastrointestinal endoscopic clip cutter generator, an MD15 import license from CDSCO’s Central Licensing Authority is mandatory.
Key steps include:
Document Preparation: Assemble all necessary technical and compliance documents.
Application Submission (Form MD14): File the import license application via the CDSCO MD Online Portal.
Query Resolution: Respond to any departmental queries.
License Grant (Form MD15): Upon approval, CDSCO issues the import license.
Notably, no test license is required for imports. The entire process takes approximately 5 to 6 months.
Import License Documents Required
Essential documents for MD15 include:
- Manufacturing License from country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale Drug License (if applicable)
- Company Constitution and Incorporation Certificate
For detailed information, consult our Import License Guide.
Timeline and Processing Duration
| License Type | Total Duration | Key Milestones |
|---|---|---|
| MD9 Manufacturing | 4 to 5 months | Test License (1.5-2 months), Testing, Audit, Query Resolution |
| MD15 Import | 5 to 6 months | Document Review, Query Resolution |
Planning ahead and preparing comprehensive documentation expedite the approval process.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 Manufacturing | ₹50,000 | ₹1,000 per product |
| MD15 Import | $3,000 (Class C & D) | $1,500 per product |
Additional costs include fees for product testing, audits, and consultancy if engaged.
Common Challenges and Solutions
- Incomplete Documentation: Missing or inconsistent paperwork leads to delays. Solution: Use comprehensive checklists and expert reviews.
- Delayed Testing: Limited slots at approved labs can bottleneck. Solution: Schedule testing early and consider multiple labs.
- Audit Non-compliance: Facility or process gaps cause audit failures. Solution: Conduct internal pre-audits and staff training.
- Query Resolution Delays: Slow responses stall approvals. Solution: Assign dedicated regulatory personnel to manage queries efficiently.
Our experience across 500+ companies enables us to preempt these challenges effectively.
Expert Consultation and Support
Engaging a seasoned regulatory consultant can transform a complex CDSCO licensing journey into a streamlined process. We offer:
- Tailored regulatory strategy for Class C devices
- End-to-end documentation support
- Liaison with CDSCO and notified bodies
- Training and mock audits
Partnering with experts reduces time-to-market and enhances compliance confidence.
Getting Started with Your CDSCO License Application
To initiate your CDSCO MD9 license application for the gastrointestinal endoscopic clip cutter generator:
Assess Device Classification: Confirm Class C status and applicable standards.
Gather Documentation: Begin compiling your Device Master File, Plant Master File, and QMS records.
Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal.
Schedule Product Testing: Coordinate with CDSCO-approved laboratories early.
Prepare for Audit: Conduct internal readiness assessments.
Submit Manufacturing License Application: File Form MD7 after successful testing.
Engage with CDSCO: Respond promptly to queries and inspection feedback.
By following these actionable steps and leveraging our expertise, your company can efficiently navigate the regulatory landscape and successfully commercialize your gastrointestinal endoscopic clip cutter generator in India.
